UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036115
Receipt number R000041140
Scientific Title Analyses of the skin molecules in patients with Parkinson's disease(2)
Date of disclosure of the study information 2019/03/08
Last modified on 2020/11/19 15:22:29

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Basic information

Public title

Analyses of the skin molecules in patients with Parkinson's disease(2)

Acronym

Analyses of the skin molecules in patients with Parkinson's disease(2)

Scientific Title

Analyses of the skin molecules in patients with Parkinson's disease(2)

Scientific Title:Acronym

Analyses of the skin molecules in patients with Parkinson's disease(2)

Region

Japan


Condition

Condition

1.Healthy adults
2.Parkinson's disease

Classification by specialty

Neurology Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of differences of skin molecules between healthy adults and Parkinson's disease.

Basic objectives2

Others

Basic objectives -Others

The observational study of the relationship between skin molecules and states of Parkinson's disease.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The differences of skin molecules between healthy subjects and subjects with Parkinson's disease.

Key secondary outcomes

The differences of blood components between healthy subjects and subjects with Parkinson's disease.

The relationship of the molecules between skin and blood.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

89 years-old >=

Gender

Male

Key inclusion criteria

[The criteria for healthy subjects]
1.Healthy panelists who are 40-89 years old without Parkinson's disease.
2.Panelists who agree to have their typical daily routines.
3.Panelists who don't require assistance to participate in this trial.
4.Panelists who don't require the legally acceptable representatives.

[The criteria for subjects with Parkinson's disease]
1.Panelists with sporadic Parkinson's disease (Hoehn & Yahr stage I or II).
2.Japanese male panelists who are 40-89 years old.
3.Panelists who agree to have their typical daily routines.

Key exclusion criteria

1.Panelists who have the type I or II diabetes.
2.Panelists who have the malignant tumors.
3.Panelists who have the skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis vulgaris.
4.Panelists who have the infectious diseases, such as HIV, HCV, HIV, and syphilis.
5.Panelists who use the antibiotics within 2 weeks before participation in this study.
6.Panelists who use the prescription drugs having any effects to this study.
7.Panelists who use the prescription topical agents on the face
8.Panelists who is considered as inappropriate in this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayoshi Inoue

Organization

Kao Corporation

Division name

Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7498

Email

inoue.takayoshi@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Yuya Uehara

Organization

Kao Corporation

Division name

Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7461

Homepage URL


Email

uehara.yuuya@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Juntendo University

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

順天堂大学医学部付属順天堂医院(東京都)
株式会社インフォワード恵比寿スキンリサーチセンター(東京都)


Other administrative information

Date of disclosure of the study information

2019 Year 03 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 02 Month 28 Day

Date of IRB

2019 Year 02 Month 28 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2020 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 11 Month 19 Day


Other

Other related information

The observational study of the relationship between skin molecules and states of Parkinson's disease.


Management information

Registered date

2019 Year 03 Month 07 Day

Last modified on

2020 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041140


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name